MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - DRILL, AO SMALL D4.2X300MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	UNKNOWN
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported by the customer that "while surgeon was drilling a hole with a 4.2mm drill bit for a distal screw in a short gamma nail procedure the tip of the drill bit broke off inside the patient's femur.Unable to remove broken tip of drill bit.New drill bit was acquired and used to complete the procedure.".
Additional Manufacturer Narrative
Correction to d9(product available to stryker) and h6(component code grid).The reported event could not be confirmed since the affected device was not returned and no evidence was provided for evaluation.The batch record could not be reviewed because the affected device was not returned, and the lot number communicated was incorrect.No corrective actions are required at this time.Indications of material, manufacturing, or design related problems were unable to identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More information as well as the affected device must be available in order to confirm and determine the exact root cause of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported by the customer that "while surgeon was drilling a hole with a 4.2mm drill bit for a distal screw in a short gamma nail procedure the tip of the drill bit broke off inside the patients femur.Unable to remove broken tip of drill bit.New drill bit was acquired and used to complete the procedure.".

• Brand Name: GAMMA3 - DRILL, AO SMALL D4.2X300MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23875436
• Report Number: 0008031020-2025-02212
• Device Sequence Number: 5571125
• Product Code: LXH
• UDI-Device Identifier: 04546540377883
• UDI-Public: 04546540377883
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN
• Device Catalogue Number: 13203042
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown